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Tests treatment safety and results for Pleural Effusion Associated With Pulmonary Infection
Official title Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections [LYTICS +]
ClinicalTrials.gov ID: NCT06713382
What this study is testing
What is Pleural Saline Irrigation?
Pleural Saline Irrigation is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pleural effusion associated with pulmonary infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this protocol is to conduct a pilot prospective non-blind clinical trial to evaluate the efficacy and safety of a novel saline irrigation technique as an adjunct to standard interventions for treating retained pleural infections. Intrapleural fibrinolytic therapy (IPFT) is commonly used for infections not adequately managed with antibiotics and intercostal tube drainage, while saline irrigation serves as an alternative for cases with a high bleeding risk where IPFT is not feasible.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years.
- Presence of purulent pleural fluid or pleural fluid analysis with any of the following:
- pH ≤ 7.2.
- Glucose \< 40 mg/dL.
- LDH \> 1000 IU/L.
You likely can't join if
- Inability to provide informed consent.
- Pregnant patients.
- Patients with significant comorbidities that may interfere with the study -outcomes (e.g., terminal malignancy).
- Complicated sympathetic effusion.
- Hepatic hydrothorax.
See the full eligibility criteria
- Age ≥18 years.
- Presence of purulent pleural fluid or pleural fluid analysis with any of the following:
- pH ≤ 7.2.
- Glucose \< 40 mg/dL.
- LDH \> 1000 IU/L.
- Presence of bacterial or fungal organisms on Gram stain or culture.
- Chest tube placement with less than 200 mL drainage in 24 hours.
- Indication for IPFT treatment based on treating physician's criteria.
- Radiographic evidence of septations on chest ultrasound (US) or loculations on low-dose chest computed tomography (CT).
- Inability to provide informed consent.
- Pregnant patients.
- Patients with significant comorbidities that may interfere with the study -outcomes (e.g., terminal malignancy).
- Complicated sympathetic effusion.
- Hepatic hydrothorax.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.